How many controls does EU Clinical Trials Regulation have?

EU Clinical Trials Regulation contains 17 controls organized across 4 domains.

Where does EU Clinical Trials Regulation apply?

EU Clinical Trials Regulation is applicable in European Union. Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.

What frameworks does EU Clinical Trials Regulation map to?

EU Clinical Trials Regulation has control-to-control mappings with 506 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.

How do I get started with EU Clinical Trials Regulation compliance?

Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.

EU Clinical Trials Regulation (CTR 536/2014)

Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. Replaces the Clinical Trials Directive 2001/20/EC.

Domains

Chapter VIII-XI — Supervision and Transparency

Chapter II — Application and Authorisation

Chapter III — Subject Protection

Chapter V-VII — Safety Reporting and GMP

Frequently Asked Questions

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